Senior Medical Device Quality Engineer - Regulatory & Risk
Katalyst CRO
Katalyst CRO is seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance. This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global #J-18808-Ljbffr Katalyst CRO
- Job-ID32715582Reference26-01278 Job Summary: Seeking a Senior Medical Device Quality & Compliance Engineer with expertise in Medical Device Quality Systems, Regulatory Compliance, Design Transfer, Risk Management, and Quality Engineering. The ideal candidate will support...SeniorRiskRegulatory
- ...worldwide.We’re a team of engineers, clinicians, and... ...looking for a strong quality functional leader to support... ...on design controls, risk management, process... ...external design control and regulatory requirements.Roles &... ...DegreeExpertise in medical device standards such as ISO...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours
- ...Intuitive Surgical seeks a senior quality engineer to lead design controls, risk management, and regulatory compliance for next-generation surgical systems. The role... ...transfer, and FDA submissions across complex medical devices. Responsibilities Plan and execute design...SeniorRiskRegulatory
$136k - $184k
...with Outset, a trailblazing medical device company that is... ...love.Position Overview:The Senior Software Quality Engineer is responsible for performing... ...management, product management, regulatory, human factors, and... ...safety and cybersecurity risk evaluation and deployment...SeniorRiskRegulatoryFor contractorsLocal areaImmediate start- ...worldwide.We’re a team of engineers, clinicians, and... ...PositionThe Digital Senior Clinical Development... ...into requirements, risk assessments,... ...human factors, product, regulatory, and quality teams to define requirements... ...of experience in medical device industry with a...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours
- ...surgery and minimally invasive care, seeks a Senior Software Quality Engineer to lead independent quality oversight for SaMD... ...software engineering knowledge and the ability to challenge technical decisions with objective risk-based assessment, #J-18808-Ljbffr Regulatory JobsSeniorRiskRegulatory
- ...Senior Software Quality Engineer at Outset Medical supports design assurance for medical device software across the development lifecycle. This role collaborates with R&D, regulatory, manufacturing, and testing teams to ensure... ...and cybersecurity risk management including...SeniorRiskRegulatoryFull time
- ...Sr.Principal Supplier Quality Engineer to join our team in... ...supplier management and risk mitigation strategies... ...a trusted advisor to senior leadership regarding... ..., reliability, regulatory, or business risks.Champion... ..., aerospace, medical devices, or other highly regulated...SeniorRiskRegulatoryFull timeWork at officeWorldwide
- Intuitive Surgical is seeking a Senior Clinical Development Engineer to define, develop, and validate... ...clinical requirements ensuring high-quality patient outcomes.... ...clinical performance, documenting risks, and supporting regulatory submissions while maintaining cutting...SeniorRiskRegulatory
- ...worldwide.We’re a team of engineers, clinicians, and... ...of PositionThe Senior Software Quality Engineer serves as a... ...oversight for Software as a Medical Device (SaMD), Software in... ..., Product Security, Regulatory Affairs, and Product... ...identify technical risks, influence software...SeniorRiskRegulatoryLocal areaWorldwideFlexible hoursShift work
- ...worldwide.We’re a team of engineers, clinicians, and... ...Function of Position The Senior Quality Engineer supports... ..., design controls, risk management, anomaly tracking... ...software used in our medical devices.Essential Job... ...traceability matrices.Regulatory Support:Support Regulatory...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours
- ...Intuitive Surgical seeks a Senior Software Quality Engineer to provide independent... ...oversight for software-based medical devices, digital health solutions... ...while maintaining regulatory compliance and objective... ...reliability, and cybersecurity risks early Assess software...SeniorRiskRegulatory
$140.5k - $183k
...Supplier Industrialization, Manufacturing Engineering, or Quality Engineering, with a strong focus on... ...to translate complex technical risks into clear, actionable insights for executive... ...technologies in an aerospace or high regulatory environment. Areas of expertise include...SeniorRiskRegulatoryLocal areaImmediate startWorldwideVisa sponsorship- Intuitive Surgical, Inc. is seeking a Senior Clinical Development Engineer to apply deep clinical and technical... ...and clinicians to assess clinical risks, support regulatory documentation, and help ensure patient safety and high-quality outcomes across our multi-port platforms...SeniorRiskRegulatory
- ...Senior Quality Engineer supporting medical device software development from concept through commercialization. Ensures compliance with regulatory standards including ISO 13485, FDA 21 CFR Part 820, and IEC... ...in design controls, risk management, and software validation...SeniorRiskRegulatory
$140k - $150k
...Senior Quality Engineer Santa Clara, CA Senior Quality Engineer Job... ...customer satisfaction, and regulatory compliance. This role is ideal... ...data to identify risks and drive data-based improvement... ...package including: ~ Medical, Dental, and Vision insurance...SeniorRiskRegulatoryFull timeTemporary workSummer holidayWorldwideFlexible hours$95k - $105k
...highly experienced and driven Senior Quality Engineer to join our team. In this... ...qualification builds, and risk assessments for new materials... ..., customer, supplier, and regulatory audits by ensuring... ...benefits package including medical, dental, and vision insurance...SeniorRiskRegulatoryFull timeTemporary workWork at officeLocal areaShift workDay shift- ...worldwide. We're a team of engineers, clinicians, and... ...in design for non-FDA regulatory compliance (Safety and... ...include design validation, risk analysis, and design... .../wireless and Safety medical standards and testing... ...and non-medical device test projects and approval...SeniorRiskRegulatoryLocal areaWorldwideFlexible hoursShift work
- ...RemoteJob Summary:We are seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have... ...in medical device quality systems, risk management, complaint handling, post-market...SeniorRiskRegulatory
- ...worldwide.We’re a team of engineers, clinicians, and... ...requirements, consider clinical risks and identify solutions... ...members including regulatory, human factors,... ...MSExperienced in driving medical device products and features... ...marketing, regulatory, quality, product design, engineering...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours
- .... Were a team of engineers, clinicians, and... ...Function of PositionThe Senior Clinical Research... ...clinical risks, and providing design... ...to evaluate device performance, safety... ...teams—including regulatory, quality, clinical affairs... ...disease states and medical technologies associated...SeniorRiskRegulatoryFull timeLocal areaWorldwideRelocationFlexible hours
$180k - $200k
...Job Overview: The Senior Quality Engineer will participate in... ...of Willow Innovations medical breast pump products... ...manufacturing, quality, regulatory, and clinical affairs... ...teams to implement risk-based approaches to... ...10 years in medical device quality engineering with...SeniorRiskRegulatory- ...We’re a team of engineers, clinicians,... ...the PositionThe Senior Clinical Development... ...and medical technology to work... ...ensure a high-quality patient outcome... ...document clinical risks, and identify appropriate... ...Support regulatory documentation... ...experience in medical device industry with a...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours
$114.6k - $157.6k
...Twitter) and Facebook. The Senior Quality Engineer plays an integral role in... ...guidance for Design Controls, Risk Management, and decisions... ...molecular diagnostics, or medical devices preferred).Experience in... ..., ethical standards, and regulatory requirements to improve the...SeniorRiskRegulatoryFull timeWork at officeWork from home$114.6k - $157.6k
...Guardant Health seeks a Senior Quality Engineer to oversee quality activities for IVD product development... .... The role involves design controls, risk management, supplier oversight, and cross-functional guidance to ensure regulatory compliance and product quality....SeniorRiskRegulatoryFull time- ...while addressing environmental challenges in the food supply chain. The Senior Machine Safety and Compliance Engineer will lead safety engineering, perform risk assessments, and ensure regulatory compliance for the automated system, collaborating with cross-functional...SeniorRiskRegulatory
- ...Position: This Sr. Clinical Development Engineer (CDE) position reports to the Clinical... ...engineering requirements, consider clinical risks and identify solutions to guide product... ...cross functional team members including regulatory, human factors, training, engineering...SeniorRiskRegulatoryFlexible hours
$157.9k - $213.6k
...that designs and engineers high-profile consumer... ...we have produced devices like Fire tablets,... ...us create?The Sr. Regulatory Compliance... ...regulatory intelligence, risk assessment, and compliance... ...effectively to senior leadership as... ...health insurance (medical, dental, vision, prescription...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours$157.9k - $213.6k
...company that designs and engineers high-profile consumer... ..., we have produced devices like Fire tablets, Fire... ...looking for a Sr. HW Regulatory Compliance Engineer who... ...compliance readiness, perform risk assessments, and guide... ...health insurance (medical, dental, vision,...SeniorRiskRegulatoryLocal areaWorldwideFlexible hours- ...Senior Clinical Development Engineer responsible for defining, developing, and validating... ...pre-clinical testing and regulatory support.... ...pre-clinical testing and risk assessment to validate safety... ...Requirements ~8+ years medical device industry experience with...SeniorRiskRegulatory
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